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MK-1942 for Major Depressive Disorder

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 15: 12 (daily dose) or 72 (intermittent dose) hours postdose

Summary

This trial is testing a new drug called MK-1942 to see if it helps people with depression that doesn't improve with regular treatments. The goal is to find out if MK-1942 can reduce depression symptoms.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 15: 12 (daily dose) or 72 (intermittent dose) hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 15: 12 (daily dose) or 72 (intermittent dose) hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in MADRS Total Score to Week 1
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3
Number of Participants Who Discontinued Study Treatment Due to an AE
+1 more
Secondary study objectives
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 1
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3
Change From Baseline in the HAM-D17 Scale Total Score to Week 1
+2 more

Side effects data

From 2022 Phase 1 trial • 27 Patients • NCT04308304
13%
Nausea
7%
Dyspepsia
7%
Alanine aminotransferase increased
7%
Aspartate aminotransferase increased
7%
Pruritus
7%
Nystagmus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Bid
MK-1942 50 mg BID & Days
MK-1942 8 mg BID 7 Days
MK-1942 30 mg Bid 7D
MK-1942 15 mg BID 7 Days
MK-1942 Total

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-1942 Intermittent Dose GroupExperimental Treatment2 Interventions
Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Group II: MK-1942 Daily Dose GroupExperimental Treatment2 Interventions
Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Group III: PlaceboPlacebo Group1 Intervention
Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1942
2021
Completed Phase 1
~30
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,582,397 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
4,001 Previous Clinical Trials
5,184,812 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,881 Previous Clinical Trials
8,088,103 Total Patients Enrolled

Media Library

MK-1942 Clinical Trial Eligibility Overview. Trial Name: NCT04663321 — Phase 2
Major Depressive Disorder Research Study Groups: MK-1942 Daily Dose Group, MK-1942 Intermittent Dose Group, Placebo
Major Depressive Disorder Clinical Trial 2023: MK-1942 Highlights & Side Effects. Trial Name: NCT04663321 — Phase 2
MK-1942 2023 Treatment Timeline for Medical Study. Trial Name: NCT04663321 — Phase 2
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04663321 — Phase 2
~22 spots leftby Nov 2025